https://medicaldevicecourses.com/members/bryan-xavier/activity/ Activity feed for Bryan Xavier. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ca28a05f61a05da8a94dbe5efd946ef2 https://medicaldevicecourses.com/activity/p/33742/ Mon, 17 Nov 2025 18:48:13 -0500 Many times in the weekly lesson, we learn about two ways to run a part of a company or project, and we often learn that most versatile is a balance between the two. I think this is also similar to…   Read more»

]]> 38e6fa69c83480da603ac9f6badb1485 https://medicaldevicecourses.com/activity/p/33741/ Mon, 17 Nov 2025 18:09:30 -0500 Besides the type of project determining what type of matrix is used, another factor that should determine the matrix used is the amount of risk the produce has if it fails. Any device that is life-supporting have very high patient…   Read more»

]]> 30f1e782d594d8b256646ed590ee3d0f https://medicaldevicecourses.com/activity/p/33740/ Mon, 17 Nov 2025 17:18:03 -0500 To meet the value-based care expectations, medical device companies could also focus on creating internal teams that focus on making their medical devices more accessible across more places. This could mean making devices easier to use or to be trained…   Read more»

]]> 0a02047366c8c9d95253d0d2920f94e2 https://medicaldevicecourses.com/activity/p/33619/ Tue, 11 Nov 2025 04:46:57 -0500 I think documentation of each potential risk found and measures to deal with it, whether it be avoidance or mitigation. It’s important that if a risk it found, there’s no way for it to appear frequently once the product reaches…   Read more»

]]> 206f5f4d163f256c573a907f6690a3b7 https://medicaldevicecourses.com/activity/p/33618/ Tue, 11 Nov 2025 04:20:11 -0500 I think the distinction is important because they happen at different stages, and thus must be managed differently. Hazards are managed by prevention to stop the danger from ever happening in the first place. That’s why regular maintenance is usually…   Read more»

]]> ccd0f30f4ef2c5f79ce089af9ff3448a https://medicaldevicecourses.com/activity/p/33608/ Mon, 10 Nov 2025 19:51:25 -0500 I think a good way to decided what levels of residual risk is acceptable is to create a quantifiable way to measure it, instead of leaving it up to opinions. The scale would make it clearer for how often the…   Read more»

]]> 84a3bf8489d4bb985da88d988e512e3d https://medicaldevicecourses.com/activity/p/33566/ Sun, 09 Nov 2025 20:23:19 -0500 The failure of the DePuy hip implant is probably due to not enough diversity in the testing population. Real world patients can vary widely in weight, height bone density and levels of physical activity can affect an implant’s effectiveness over…   Read more»

]]> 7f5612c31814e219087b4e8064e0333d https://medicaldevicecourses.com/activity/p/33561/ Sun, 09 Nov 2025 18:51:03 -0500 A good CM manufacturer should validate machines and have a maintenance plan, and also provide full documentation for proof that the process works the same way every time. The document should have test plans, results and checks if the equipment…   Read more»

]]> 41e2fb176adfda27114406e91f447406 https://medicaldevicecourses.com/activity/p/33560/ Sun, 09 Nov 2025 18:29:39 -0500 I agree that multiple review meeting should be made during a medical device’s lifecycle. Deciding on how many meetings are happening should be governed by what goals must be met before being able to move on to the next step….   Read more»

]]> b02057acd586163af7a3978250c8955b https://medicaldevicecourses.com/activity/p/33388/ Fri, 31 Oct 2025 12:43:14 -0400 I would probably say that this is more a case by case approach. For devices or features that are high risk, verifications and validation should be strictly separate to keep results trustworthy. But for lower risk features, you can afford…   Read more»

]]> bda1487a277dec08b8d4cf3763c21ddd https://medicaldevicecourses.com/activity/p/33386/ Fri, 31 Oct 2025 03:55:53 -0400 How about instead you design the DHF around making it easier for the reviewer to read it in mind, rather than the regular documents? Starting with a one-page index of the most critical user needs and for each one, creating…   Read more»

]]> 020ef02359c2509c95e198bc29daedae https://medicaldevicecourses.com/activity/p/33385/ Fri, 31 Oct 2025 03:35:38 -0400 Design control can actually be better for innovation, as it acts as a filter that would let ideas that wouldn’t pass regulation be rejected immediately, and the constraints would force for more unique innovations that still manage to be within…   Read more»

]]> 8d1caf38468aaaea201c2f0a6685254a https://medicaldevicecourses.com/activity/p/33318/ Sun, 26 Oct 2025 17:36:33 -0400 An important guideline for medical companies is ensuring data integrity in clinical research. This is where the ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) comes in, and what CRAs look for regarding documents and…   Read more»

]]> 2366a1d00210f1bb0c781ece2b630766 https://medicaldevicecourses.com/activity/p/33317/ Sun, 26 Oct 2025 17:00:40 -0400 Along with everything else, everyone has mentioned, biomedical engineers also help with making sure that what a clinical trial measures actually matters. The study has to show specific results that show whether a device worked or not. Engineers help translate…   Read more»

]]> b576232d9aeff026e65d35cca190bdfa https://medicaldevicecourses.com/activity/p/33316/ Sun, 26 Oct 2025 12:24:00 -0400 While GCP regulations can slow development, the FDA has several programs in place that see to expedite the wait time. In class when learning about the specific pathways that medical products can take, we also learned about Investigational Device Exemption…   Read more»

]]> 1fe0a52e6dfdf0c9135d9cb7c2764f79 https://medicaldevicecourses.com/activity/p/33207/ Sun, 19 Oct 2025 12:49:12 -0400 You can make medical device marketing more ethical and accurate by doing a human-factors testing, something similar to testing that’s done during device design. Before releasing ads about the product to the public, companies could first show them to a…   Read more»

]]> adff5c7326832d757eec485a43d0c52e https://medicaldevicecourses.com/activity/p/33206/ Sun, 19 Oct 2025 12:27:25 -0400 I think one way to keep medical device marketing effective while still being ethical is implementing something similar to a traceability matrix into the marketing process. This would require every statement used in marketing to be required to be connected…   Read more»

]]> 28e2c63db097a955108253c9113790f2 https://medicaldevicecourses.com/activity/p/33205/ Sun, 19 Oct 2025 11:59:46 -0400 For marketing products in general, knowing who your audience is can determine how to optimize your marketing strategy towards that audience. For medical devices specifically, that audience would typically be the hospital’s internal evaluation group rather than just physicians. Most…   Read more»

]]> 2a743f35eb61831d0ee556bb6762864f https://medicaldevicecourses.com/activity/p/32936/ Thu, 09 Oct 2025 03:26:27 -0400 Physicians branching out into entrepreneurship can have positive effects on healthcare. However, access can also be an issue with newly developed technologies. Not every community will equally benefit from those innovations. Telehealth, for example, requires that patients have reliable access…   Read more»

]]> b69bc0e6853b0d669d451127e41394e3 https://medicaldevicecourses.com/activity/p/32897/ Wed, 08 Oct 2025 04:07:14 -0400 I think that the corporate veil is an important protection that allows people to take on the risk of starting a company or investing in one in the first place. Without that protection, the uncertainty of a business surviving or…   Read more»

]]> a9f33f6671fc1e778606d03a6ccde006 https://medicaldevicecourses.com/activity/p/32844/ Tue, 07 Oct 2025 04:25:53 -0400 Recently, Electronic Arts (EA), a once publicly traded company, agreed to a deal that will make it go private Once this transition happens, EA will no longer have to publish quarterly earnings that allow shareholders to decide whether they want…   Read more»

]]> c61862ee8b0a4e0ef61510aea466bc0d https://medicaldevicecourses.com/activity/p/32782/ Mon, 06 Oct 2025 03:01:41 -0400 Obviously, AI is already being heavily researched and expanded on, with many companies finding way on how to seamlessly implement it into their system. AI can indeed help handle routine pats, like checking if training is up-to-date, finding documents or…   Read more»

]]> 41bfb7efa0e9ed7a7042dede6550fd82 https://medicaldevicecourses.com/activity/p/32779/ Mon, 06 Oct 2025 02:53:09 -0400 It’s true that having things be more measurable makes it easier to provide clear results. One way I see of preventing that can be to create a checklist between QA and QC that explains what standards QA expects, and QC…   Read more»

]]> 2401c01eb26e0131c17975316e6de162 https://medicaldevicecourses.com/activity/p/32777/ Mon, 06 Oct 2025 02:49:43 -0400 While creating one unified quality system sound more efficient, it can actually create more problems when companies work in different regions. Depending on the countries, their rules can be different, like different reporting timelines. If a company forces all other…   Read more»

]]> 6cf085c5e3d60844006a5417b23dae66 https://medicaldevicecourses.com/activity/p/32452/ Sun, 28 Sep 2025 03:47:23 -0400 The FDA’s Breakthrough Devices and Safer Technologies (STeP) programs are designed to speed up innovation for unmet medical needs. It gives manufacturers earlier and more frequent interactions with reviewers and review timelines, helping unique promising technologies reach patients that need…   Read more»

]]> 7fcf6a5e2de036f4e38284ba3e59daca https://medicaldevicecourses.com/activity/p/32450/ Sun, 28 Sep 2025 02:38:28 -0400 The FDA’s classification framework works well for physical devices because risk is tied to how much contact the patient makes with the device. Software wouldn’t exactly work with that classification, due to the danger coming from inaccurate readings rather than…   Read more»

]]> 4e1ab2a00b39aa4c914f554d28f7ee61 https://medicaldevicecourses.com/activity/p/32449/ Sun, 28 Sep 2025 01:46:17 -0400 I think the classification that the project will be in can also affect how early or late creative freedom should be considered. Since different classes will have pathways with varying qualifications they need to follow, the classes that require fewer…   Read more»

]]> 3d417cbf530ae8a9de66c218fcade3f6 https://medicaldevicecourses.com/activity/p/32136/ Sat, 20 Sep 2025 10:44:04 -0400 Testing biocompatibility during the designing process is important, but biocompatible for the device has to be managed across its entire lifecycle. If a new method is used when making a product, like a different supplier, reassuring biocompatibility after is a…   Read more»

]]> bd16d8831fbaf0fadb916aa8e282b38b https://medicaldevicecourses.com/activity/p/32135/ Sat, 20 Sep 2025 10:26:09 -0400 @krish I definitely agree with you that organ on a chip model are slowly reducing our dependence on animal studies. The FDA themselves have also pushed for this, as the FDA Modernization Act 2.0 allows for organ on a chip…   Read more»

]]> 59cd6d2a466672ca9cb71d3b01d113a8 https://medicaldevicecourses.com/activity/p/32132/ Sat, 20 Sep 2025 09:44:50 -0400 I have just started working in the biopharmaceutical industry, and one of the things they really hammer down is following protocol in order to stay within federal regulations. If we slip out of compliance, production can be stalled or even…   Read more»

]]> 36aef3d7d1683f396770c1dfe57582c0 https://medicaldevicecourses.com/activity/p/31838/ Thu, 11 Sep 2025 01:33:14 -0400 It’s fine to consider some innovation, as long you can differentiate something the project truly needs and is worth the potential extra time and resources to enact this change. In my experience working on a product, we make a list…   Read more»

]]> 4a967bc3ff54f376a710ff988c8dada8 https://medicaldevicecourses.com/activity/p/31837/ Thu, 11 Sep 2025 00:54:28 -0400 I agree with having feasibility check at the initiation phase of the project. However, to add to that, maybe it would be good practice to hold a risk assessment meeting and come up with a certain condition where it becomes clear…   Read more»

]]> e64d743bf21693537053470f2e61c811 https://medicaldevicecourses.com/activity/p/31836/ Thu, 11 Sep 2025 00:04:32 -0400 Depending on the severity of the disagreement, it can be helpful to the team if you also bring an outside perspective, specifically someone who has faced an issue similar to the one causing the disagreement. This way, it feels less…   Read more»

]]> 2af2b07c2c5857c4bc288160eb8d64c9 https://medicaldevicecourses.com/activity/p/31722/ Thu, 04 Sep 2025 21:12:50 -0400 I actually see the jack of all trades aspect of BME having some positive outcomes in my own experience. For me specifically, I wanted to focus on data analysis focus jobs, but because I also had experience working in biolabs…   Read more»

]]> 83fdc4ca9dfb63ec548cf6794716c6dc https://medicaldevicecourses.com/activity/p/31721/ Thu, 04 Sep 2025 20:35:57 -0400 I’d lean more toward more co-ops or longer internships, due to the multiple years of experience employer often expect for a lot of jobs. For students, co-op can give the student the required experience while being able to juggle both…   Read more»

]]> 99e80f3735585d75c72472b4e5ff5883 https://medicaldevicecourses.com/activity/p/31718/ Thu, 04 Sep 2025 20:04:35 -0400 I also see myself drawn to industry. For me, it’s mostly because I feel more comfortable dealing with a defined problem with a set deadline rather than the more open-ended approach. I’ve noticed that tangible progress motivates me more, and…   Read more»

]]> 86d04d71aba18c8d73c279e4420f14b1 https://medicaldevicecourses.com/activity/p/31473/ Wed, 30 Apr 2025 04:17:55 -0400 To make the team aware of risk on even smaller, simpler projects, you could incorporate short “Risk Sprints” in regular intervals of the planning cycle. In each of these meetings, the team will look for new risks that can possible…   Read more»

]]> 28bbf79ef21f1b9c31930ca410012e4c https://medicaldevicecourses.com/activity/p/31471/ Wed, 30 Apr 2025 03:49:17 -0400 One way of convincing management to invest in more contingency planning is to remind them that it is a regulatory and compliance risk. If the primary supplier cannot meet quality standards post its approval, that can cause major delays in…   Read more»

]]> ffaabd87cfa68fd2e8c8cfb1ed860c4f https://medicaldevicecourses.com/activity/p/31470/ Wed, 30 Apr 2025 03:13:31 -0400 For long-running clinical trials, there are many ways to maintain engagement and motivation among team members. One way is to celebrate small milestones, like completing a trial phase. Showing appreciation for these small victories allows the team to more easily…   Read more»

]]> 0367a5eb04fb96e19c3ce69c4c4f639f https://medicaldevicecourses.com/activity/p/31381/ Wed, 23 Apr 2025 18:34:14 -0400 One obstacle that can complicate timeline planning for large scale clinical trials is the variability added by conducting trials across multiple countries. Global trials come with more complexity that can’t always be covered by traditional tools like Gantt Charts. Each…   Read more»

]]> 272ddb61b2cb133b40f7e7625685ffdc https://medicaldevicecourses.com/activity/p/31380/ Wed, 23 Apr 2025 17:34:13 -0400 The first step should be to identify why the underperformance is happening, which can lead to visits to monitor process or talking to the team themselves to find the root cause. Then the necessary changes can be made to see…   Read more»

]]> 02dca3c480432a86bd991802cc0c26fd https://medicaldevicecourses.com/activity/p/31379/ Wed, 23 Apr 2025 16:49:02 -0400 One strategy that can be used for keeping clinical research teams motivated is to create and celebrate short-term wins. It was mentioned in this week’s slides that one motivator for people is team based praise, so breaking the project into…   Read more»

]]> ca92ce1c60a1433e9ca3f1895bee799a https://medicaldevicecourses.com/activity/p/31303/ Thu, 17 Apr 2025 04:36:53 -0400 @ms3548 I think the way to managing the transition from broad to bottom-up estimating is to treat it as a planned-hand off. For example, scheduling a formal review point once enough detail is available, like a completed WBS or when…   Read more»

]]> 0db10b36bb7e31093055007d465f2d08 https://medicaldevicecourses.com/activity/p/31301/ Thu, 17 Apr 2025 04:26:51 -0400 In addition to balancing detail and simplicity for the WBS, I think it’s also important the WBS structure has clear traceability between work and regulatory paperwork, like design inputs, outputs, verification and validation. If the WBS is too high-level, it…   Read more»

]]> a3f2ac3e02de3d37221ecff48390e47f https://medicaldevicecourses.com/activity/p/31300/ Thu, 17 Apr 2025 04:13:16 -0400 I agree that regulatory approval shouldn’t be the end all be all for safety. There are multiple strategies that companies can and should take before a product hits the market. One such method is a Failure Modes and Effect Analysis,…   Read more»

]]> 850d34a929b89a6dfadde0ce25ed0f0b https://medicaldevicecourses.com/activity/p/31229/ Wed, 09 Apr 2025 01:09:36 -0400 In my experience, I’ve used weekly in person meetings in order to make actual progress in a project I’m working and discuss with coworkers. Then I use Slack and some of my free time in order to conduct more research…   Read more»

]]> 4d77a609a61c02048201f542f113bb18 https://medicaldevicecourses.com/activity/p/31228/ Wed, 09 Apr 2025 00:59:40 -0400 To build confidence in testing outcomes, companies often create a standardized test kit that includes the product sample, and instructions for handling, storage, and testing. This kit could include things like labeled materials, checklist for covering compound ratios, incubation time,…   Read more»

]]> 4a607746a1c4aea71667e25cc901eaff https://medicaldevicecourses.com/activity/p/31227/ Wed, 09 Apr 2025 00:04:56 -0400 When facing a late-stage development issue, one method to consider is using the “5 Why’s” Method, where you’re keeping asking why the failure is happening up to 5 times to determine whether the root of the problem is due to…   Read more»

]]> 6fbd62b035966288f4f081fea733fcc1 https://medicaldevicecourses.com/activity/p/31140/ Wed, 26 Mar 2025 04:51:39 -0400 In complex and highly regulated projects like medical device development, changes are bound to happen. Design updates, documentation revision, and process adjustments are required to ensure compliance and quality, but when changes become frequent, teams can experience change fatigue. This…   Read more»

]]> 28e53c039e2a9f419407d10273c53f15 https://medicaldevicecourses.com/activity/p/31139/ Wed, 26 Mar 2025 04:15:30 -0400 As much as learning from mistakes is important for future projects, it should also be important to use the lessons learned in real-time for decision makings during the project, not just as something to review afterward. If certain patterns emerge…   Read more»

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